FDA Publishes Final Rule on Direct-to-Consumer Advertising Statements of Risk

Lexology November 28, 2023
Morgan, Lewis & Bockius LLP

FDA issued the final rule Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format (Final Rule) on November 22, which follows a proposed rule on the same topic published in 2010.

Per the preamble to the Final Rule, this new regulation implements 2007 changes to the Federal Food, Drug, and Cosmetic Act (FD&C Act) requiring that human prescription drug direct-to-consumer advertisements that state the name of a drug and its conditions of use also state the major side effects and contraindications of the drug (major statement) in a clear, conspicuous, and neutral manner. (See Section 502(n) of the FD&C Act.)

Although much has changed in how...

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